Steroid Ratio Analysis for Early Preterm Delivery Risk Identification

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Solution Overview

Problem

Current methods for predicting spontaneous preterm delivery in pregnant females are limited in sensitivity and specificity, often identifying risk too late for effective interventions, and lack reliable early identification tools.

Innovation Solution

The method involves calculating ratios of specific steroids such as DOC/16αOHP and DOC/11-deoxycortisol from samples obtained from pregnant females, allowing for early identification of susceptibility to spontaneous preterm delivery by determining when these ratios fall below threshold values.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current clinical strategies for risk assessment are used, then some women at risk can be identified, but the sensitivity and specificity are limited and identification occurs too late for effective intervention

Engineering Contradiction:
Improverisk assessment accuracyVSAvoidtiming of risk identification
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs risk assessment for preterm delivery in the second trimester (weeks 14-28), which is months before potential delivery. This preliminary timing allows sufficient time for clinical interventions to be implemented if risk is identified, directly resolving the contradiction between accurate measurement and timely identification.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If current obstetric and medical history-based assessment methods are used, then risk can be assessed with available tools, but only a small percentage of women at risk are identified

Engineering Contradiction:
Improverisk identification reliabilityVSAvoidnumber of at-risk women identified
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent changes the assessment parameters from traditional obstetric and medical history factors to quantitative steroid ratio measurements (specifically progesterone metabolite ratios). This parameter transformation enables identification of a much larger percentage of at-risk women with high reliability, as the steroid ratios provide objective, measurable biomarkers that capture physiological changes preceding preterm delivery.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If available risk assessment tools are used in the mid-second trimester, then risk can be evaluated, but this is after the period of maximal benefit from interventions

Engineering Contradiction:
Improverisk evaluation accuracyVSAvoidwindow for effective intervention
Core Design Contradiction:
Measurement precisionVSDuration of action of moving object

Solution Approach 1:

The patent implements risk assessment as early as the second trimester, performing the evaluation before the optimal intervention window closes. This preliminary action ensures that if risk is identified, clinicians have adequate time to implement preventive measures during the remaining pregnancy period, maximizing the duration and effectiveness of potential interventions.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11280795B2Quantitative profiling of progesterone metabolites for the prediction of spontaneous preterm delivery
Publication Date: 2022.03.22 INDIANA UNIVERSITY RESEARCH & TECHNOLOGY CORP
  • US11280795B2 patent drawing
  • US11280795B2 patent drawing
  • US11280795B2 patent drawing

AI summary

Disclosed are methods for identifying a pregnant female who is susceptible to spontaneous preterm delivery. In particular, disclosed are methods for identifying a pregnant female who is susceptible to spontaneous preterm delivery based on ratios of steroids in samples obtained from the pregnant female.